Real-world effectiveness of a multimodal wound matrix: Outcomes in non-healing wounds

Objective. The objective of this open-label, interventional, prospective clinical study was to evaluate the effectiveness of a multimodal wound matrix (MWM) in the treatment of chronic, non-healing wounds that had failed prior therapies. The overall response rate was the proportion of patients that had greater than 40% reduction in size after 4 weeks of treatment. Secondary objectives included the percentage area reduction (PAR) after 4 and 12 weeks, incidence of ulcers closing, and changes in quality of life. Approach. An open-label, interventional, prospective cohort, real-world evidence study was conducted at 8 US wound care sites. Criteria included chronic non-healing wounds of multiple etiologies in patients with extensive comorbidities. Results were compared to data from the US Wound Registry. Results: 111 patients entered the screening phase and 63 were treated. 54 wounds were eligible for the dataset that included 18 DFUs, 19 VLUs, 2 pressure injuries, 1 surgical, 1 lower extremity wound, and 12 unclassified etiologies. The objective response rate was 42%. The 4-week PAR was 34%. The 12-week PAR was 66%. 18 wounds closed by week 12. Innovation: MWM is a formulation technology developed to address the major obstacles that prevent healing. Results were evaluated in a patient population with extensive comorbidities who had failed prior treatments and would be generally excluded from controlled trials. Conclusion: The results from this study support the contention that the multimodal wound matrix achieves substantial clinical improvement in a complex patient population not enrolled in clinical trials and demonstrates an advancement in wound management.